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The Quality Engineer will help facilitate the updating and consolidation of legacy product risk management files related to IVDR.

How You'll Make An Impact:

• Facilitating risk management assessments, updating risk plans and reports, consolidation and updating product system hazard analysis files in accordance with established company procedures and applicable standards
• Coordinate and facilitate meetings with cross functional stakeholders as needed to obtain information and data needed for completeness and accuracy of risk profiles for existing hazards, and identification of new risks and hazards as needed.  Escalate events to Management that require additional inputs or mitigations.
• Support product risk management file migration into the eQMS system including ensuring document meta data is accurate and files are accurately linked to legacy product DHF binders in coordination with DHF migration efforts.
• Assessing legacy risk documentation and identifying gaps against initial IVDR transitional activities versus new guidance documents and updates to global risk management procedures.
• Support other IVDR related technical documentation updates and gap assessments as required, including migration into eQMS as needed.

• Ability to work in an ever-shifting environment and possess a high level of patience to support cross functional teams with shifting priorities.

• A self-starter who can work independently and possesses a sense of ownership and accountability to the activities assigned to them.

What You Bring:

• Bachelor's degree or equivalent in a related technical or engineering discipline
• 2-3 years experience or equivalent combination of education and experience
• General knowledge of and application of principles and theories of quality engineering and risk management.
• Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820), and FDA CFR Part 210/211 preferred.
• General understanding of risk management regulations, principles, and application.
• Excellent critical thinking, problem solving, coordination, teamwork, communication, technical and computer skills. 
• SAP, EtQ and/or Veeva experience a plus.
• Proficient in Microsoft Office, Visio

Compensation: The estimated hourly range for this position is $40.38 to $55.76 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.  As a temporary associate, your employment will be managed directly through our approved agency provider.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.  

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation:Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.